PDF Transcript

7625-10

700x175mm (LSN-NAPP-04) (L) V1

Package leaflet: Information for the user
Targinact® 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/ 10 mg
and 40 mg/20 mg
prolonged-release tablets
Oxycodone hydrochloride and Naloxone hydrochloride
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Targinact tablets are and what they are
used for
2. What you need to know before you take Targinact
tablets
3. How to take Targinact tablets
4. Possible side effects
5. How to store Targinact tablets
6. Contents of the pack and other information
1. What Targinact tablets are and what they are
used for
Targinact is a prolonged-release tablet, which means
that its active substances are released over an extended
period. Their action lasts for 12 hours.
These tablets are only for use in adults.

Pain relief
You have been prescribed Targinact tablets for the
treatment of severe pain, which can be adequately
managed only with opioid analgesics. Naloxone is added
to counteract constipation.
How these tablets work in pain relief
These tablets contain oxycodone hydrochloride and
naloxone hydrochloride as active substances. Oxycodone
is responsible for the painkilling effect of the tablets. It is
a strong analgesic (‘painkiller’) that belongs to a group
of medicines called opioids. Naloxone is intended to
bring relief from constipation. Constipation is a typical
side effect of treatment with strong painkillers.
Restless legs syndrome
You have been prescribed Targinact tablets for the
second line symptomatic treatment of severe to very
severe restless legs syndrome in people who can’t be
treated with dopamine medicines. People with restless
legs syndrome have unpleasant sensations in their
limbs. This can start as soon as they sit or lie down
and is only relieved by an irresistible urge to move the
legs, sometimes the arms and other parts of the body. It
makes sitting still and sleeping very difficult. Naloxone
hydrochloride is added to counteract constipation.
How these tablets work in restless legs syndrome
These tablets help to relieve the unpleasant sensations
and so reduces the urge to move the limbs. Naloxone is
intended to bring relief from constipation. Constipation
is a typical side effect of treatment with strong
painkillers.

2. What you need to know before you take
Targinact tablets
Do not take Targinact tablets
• if you are allergic (hypersensitive) to oxycodone or
naloxone, or any of the other ingredients of the tablets
(listed in section 6);
• if you have breathing problems, such as breathing
more slowly or weakly than expected (respiratory
depression);
• if you suffer from a severe lung disease associated
with narrowing of the airways (chronic obstructive
pulmonary disease or COPD);
• if you suffer from a condition known as cor
pulmonale. In this condition, the right side of the heart
becomes enlarged, due to increased pressure inside
blood vessels in the lung etc. (e.g. as a result of COPD
– see above);
• if you suffer from severe bronchial asthma;
• if you have a type of bowel obstruction (paralytic
ileus) not caused by opioids;
• if you have moderate to severe liver problems.
Additionally for restless legs syndrome
• if you have a history of opioid abuse
Warnings and Precautions
Talk to your doctor or pharmacist before taking these
tablets:
• in the case of elderly or debilitated (weak) patients;
• if you have a type of bowel obstruction (paralytic
ileus) caused by opioids;
• if you have kidney problems;
• if you have mild liver problems;
• if you have severe lung problems (i.e. reduced
breathing capacity);
• if you suffer with a condition characterised by
frequent breathing stops during the night which may
make you feel very sleepy during the daytime (sleep
apnoea);
• if you have myxoedema (a thyroid disorder, with
dryness, coldness and swelling [‘puffiness’] of the
skin, affecting the face and limbs);
• if your thyroid gland is not producing enough
hormones (underactive thyroid or hypothyroidism);
• if your adrenal glands are not producing enough
hormones (adrenal insufficiency or Addison’s disease);

• if you have a mental disorder as a result of an
intoxication (toxic psychosis);
• if you suffer from gallstone problems;
• if your prostate gland is abnormally enlarged (prostate
hypertrophy);
• if you are or ever have been addicted to alcohol or
drugs, or have previously suffered from withdrawal
symptoms such as agitation, anxiety, shaking or
sweating upon stopping alcohol or drugs;
• if your pancreas is inflamed (pancreatitis);
• if you have low blood pressure (hypotension);
• if you have high blood pressure (hypertension);
• if you have heart problems;
• if you have a head injury (due to the risk of increased
brain pressure);
• if you suffer from epilepsy or are prone to fits;
• if you are also taking a type of medicine known as a
MAO inhibitor (used to treat depression or Parkinson’s
disease) e.g. medicines containing tranylcypromine,
phenelzine, isocarboxazid, moclobemide and
linezolid;
• if sleepiness or episodes of suddenly falling asleep occur.
Tell your doctor if any of the above has ever applied to
you in the past. Also, please your doctor if you develop
any of them while you are taking these tablets. The
most serious result of opioid overdose is respiratory
depression (slow and shallow breathing). This may also
cause blood oxygen levels to fall, resulting in possible
fainting, etc.
You must swallow the tablet whole, so as not to affect
the slow release of oxycodone hydrochloride from the
tablet. Do not break, chew or crush the tablets. Taking
broken, chewed or crushed tablets may lead to the
absorption of a potentially lethal dose of oxycodone
hydrochloride (see section 3: “If you take more
Targinact than you should”).
If you experience severe diarrhoea at the start of
treatment (within the first 3-5 days) this may be due to
the effect of naloxone. It may be a sign that your bowel
movements are returning to normal. If diarrhoea persists
after 3-5 days, or it gives you cause for concern, please
contact your doctor.
If you have been using another opioid, withdrawal
symptoms (such as restlessness, bouts of sweating or
muscle pain) may occur when you initially switch to

taking these tablets. If you experience withdrawal
symptoms, you may need to be specially monitored by
your doctor.
If you have been taking these tablets for a long time,
you may become tolerant. This means you may need a
higher dose to achieve the desired effect. Long-term use
of these tablets may also lead to addiction. Withdrawal
symptoms may occur if treatment is stopped too
suddenly. If you no longer need treatment, you should
reduce your daily dose gradually, in consultation with
your doctor.
As with other strong opioid painkillers, there is a risk
that you may develop a psychological dependence to
oxycodone.
Tell your doctor if you have advanced digestive or
pelvic cancers where bowel obstruction may be a
problem.
If you need to undergo surgery, please tell your doctor
that you are taking Targinact.
You may notice remains of the tablet in your stools.
Do not be alarmed, as the active ingredients will have
already been released in the stomach and gut, and
absorbed into your body.
Incorrect use of Targinact tablets
These tablets are not suitable for withdrawal treatment.
These tablets should never be abused, particularly if you
have a drug addiction. If you are addicted to drugs such
as heroin, morphine or methadone, severe withdrawal
symptoms are likely if you abuse these tablets because
they contain the ingredient naloxone. Pre-existing
withdrawal symptoms may be made worse.
You should never misuse the tablets by dissolving
and injecting them (e.g. into a blood vessel). They
contain talc, which can cause destruction of local tissue
(necrosis) and changes in lung tissue (lung granuloma).
Misuse can also have other serious consequences which
may be fatal.
The use of these tablets may produce positive results in
drugs tests.
Other medicines and Targinact tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
If you take these tablets at the same time as you take

other medicines, the effect of these tablets or the other
medicine may be changed. Tell your doctor if you are
taking:
• other strong painkillers (opioids);
• sleep medication and tranquillisers (sedatives,
hypnotics);
• medicines to treat depression;
• medicines used to treat allergies, travel sickness or
nausea (antihistamines or antiemetics);
• medicines to treat psychiatric or mental disorders
(phenothiazines, neuroleptics, antipsychotics);
• medicines that decrease the blood’s clotting ability
(coumarin derivatives), this clotting time may be
speeded up or slowed down;
• antibiotics of the macrolide type (such as
clarithromycin, erythromycin or telithromycin);
• antifungal medicines of the –azole type (such
as ketoconazole, voriconazole, itraconazole or
posaconazole);
• a specific type of medicine known as a protease
inhibitor used to treat HIV (examples include
ritonavir, indinavir, nelfinavir or saquinavir;
• cimetidine (a medicine for stomach ulcers,
indigestion or heartburn);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures, fits or
convulsions and certain pain conditions);
• phenytoin (used to treat seizures, fits or convulsions);
• a herbal remedy called St John’s Wort (also known as
Hypericum perforatum);
• quinidine (a medicine to treat an irregular heartbeat).
Targinact tablets with food, drink and alcohol
Drinking alcohol whilst taking Targinact may make
you feel more sleepy or increase the risk of serious
side effects such as shallow breathing with a risk of
stopping breathing, and loss of consciousness. It is
recommended not to drink alcohol while you’re taking
Targinact.
You should avoid drinking grapefruit juice while you
are taking these tablets.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.

Pregnancy
Use of these tablets during pregnancy should be avoided
unless your doctor thinks treatment with this medicine is
essential. If used over prolonged periods during pregnancy,
oxycodone may lead to withdrawal symptoms in the
newborn baby. If oxycodone is given during childbirth, the
baby may have breathing problems (respiratory depression).
Breastfeeding
Breastfeeding should be stopped during treatment with these
tablets as oxycodone (one of the active ingredients of your
medicine) passes into breast milk.
Driving and using machines
This medicine can affect your ability to drive as it may
make you sleepy or dizzy. This is most likely at the start of
your treatment, after a dose increase or after switching from
a different medication. These side effects should disappear
once you are on a stable dose.
This medicine has been associated with sleepiness and
episodes of suddenly falling asleep. If you experience these
side effects, you must not drive or operate machinery. You
should tell your doctor if this occurs.
• Do not drive while taking this medicine until you know
how it affects you.
• It is an offence to drive while you have this medicine
in your body over a specified limit unless you have a
defence (called the ‘statutory defence’).
• This defence applies when:
o The medicine has been prescribed to treat a medical or
dental problem; and
o You have taken it according to the instructions given
by the prescriber and in the information provided with
the medicine.
• Please note that it is still an offence to drive if you are
unfit because of the medicine (i.e. your ability to drive is
being affected).
Details regarding a new driving offence concerning driving
after drugs have been taken in the UK may be found here:
https://www.gov.uk/drug-driving-law.
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.
Targinact tablets contain lactose
These tablets contain lactose (milk sugar). If you have been
told that you have an intolerance to some sugars, contact
your doctor before taking these tablets.

3. How to take Targinact tablets
Always take these tablets exactly as your doctor has told
you. Check with your doctor or pharmacist if you are
not sure.
Targinact is a prolonged-release tablet, which means
that its active substances are released over an extended
period. Their action lasts for 12 hours.
You must swallow these prolonged-release tablets
whole so as not to affect the slow release of
oxycodone from the tablets. Do not break, chew
or crush these tablets. Taking broken, chewed or
crushed tablets may result in your body absorbing a
potentially fatal dose of oxycodone (see section 3: ‘If
you take more Targinact tablets than you should’).
Unless otherwise prescribed by your doctor, the usual
dose is:
To treat pain
Adults
The usual starting dose is 10 mg oxycodone
hydrochloride / 5 mg naloxone hydrochloride every 12
hours.
Your doctor will decide how much you should take every
day and how to divide your total daily dosage into morning
and evening doses. Your doctor will also decide on any
necessary dose adjustments during treatment depending on
your level of pain and individual sensitivity. You should be
given the lowest dose needed for pain relief. If you have
already been treated with opioids, your treatment with these
tablets may be started at a higher dose.
The maximum daily dose is 160 mg oxycodone
hydrochloride and 80 mg naloxone hydrochloride. If you
need a higher dose, your doctor may give you additional
oxycodone without naloxone. However, the maximum
daily dose of oxycodone should not exceed 400 mg. The
beneficial effect of naloxone on bowel movements may
be affected if additional oxycodone is given without
additional naloxone
If you are switched from these tablets to another another
opioid pain medication your bowel function will
probably worsen.
If you experience pain between doses, you may need to
take an additional fast-acting painkiller. These tablets
are not suitable for this. Please talk to your doctor.

If you feel that these tablets are too strong or too weak,
please talk to your doctor or pharmacist.
To treat restless legs syndrome
Adults
The usual starting dose is 5 mg oxycodone
hydrochloride/ 2.5 mg naloxone hydrochloride as
prolonged-release tablet(s) every 12 hours.
Your doctor will decide how much you should take
every day and how to divide your total daily dosage into
morning and evening doses. They will also decide on any
necessary dose adjustments during treatment. Your dose
will be adjusted according to you individual sensitivity.
You should be given the lowest dose needed to relieve
your restless legs syndrome symptoms.
If you feel that these tablets are too strong or too weak,
please talk to your doctor or pharmacist.
The maximum daily dose is 60 mg oxycodone
hydrochloride and 30 mg naloxone hydrochloride.
To treat pain or restless legs syndrome
Elderly patients
In general, no dose adjustment is necessary for elderly
patients with normal kidney and/or liver function.
Liver or kidney problems
If you have kidney or mild liver problems your doctor
may prescribe a lower dose. You must not take these
tablets if you have moderate or severe liver problems,
(see also Section 2 ‘Do not take Targinact tablets’ and
‘Take special care with Targinact tablets’ and ‘Warnings
and Precautions’).
Children and adolescents below 18 years of age
No studies have been carried out to show that these
tablets work properly in children and adolescents,
or are safe for them to take. They are therefore not
recommended for use in patients under 18 years of age.
Method of administration
Swallow your tablets whole with a glass of water. You can
take these tablets with or without food. Take them every
12 hours. For instance, if you take a tablet at 8 o’clock in
the morning, you should take your next tablet at 8 o’clock
in the evening. Do not break, chew or crush the tablets
(see section 2 ‘Warnings and precautions’).

22/02/2017 16:18

7625-10

700x175mm (LSN-NAPP-04) (L) V1

Duration of use
You should not take these tablets for any longer than you
need to. If you have been taking them for a long time
your doctor should regularly check that you still need
them.
If you take more Targinact tablets than you should
If you have taken more than the prescribed dose, you
must inform your doctor immediately.
An overdose may result in:
• a reduction in size of pupils in the eye;
• breathing more slowly or weakly than expected
(respiratory depression);
• drowsiness up to loss of consciousness;
• low muscle tone (hypotonia);
• reduced pulse rate;
• a fall in blood pressure.
In severe cases, loss of consciousness (coma), fluid on
the lungs and circulatory collapse may occur, which may
be fatal.
You should avoid situations which require you to be
alert, e.g. driving.
If you forget to take Targinact tablets,
or if you take a lower dose than the one prescribed, you
may not feel any effect.
If you should forget to take your dose, please follow the
instructions below:
• If your next usual dose is due in 8 hours or more: Take
the forgotten dose immediately and continue with your
normal dosing routine.
• If your next usual dose is due in less than 8 hours:
Take the forgotten dose, then, wait another 8 hours
before taking your next dose. Try to get back in your
normal dosing routine (e.g. 8 o’clock in the morning
and 8 o’clock in the evening).
Do not take more than one dose within any 8 hour period.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Targinact tablets
Do not stop taking these tablets without first speaking
with your doctor. If you do not require any further
treatment, your doctor will advise you how to reduce
the daily dose gradually. In this way, you will avoid
withdrawal symptoms, such as restlessness, bouts of
sweating and muscle pain.

If you have any further questions on the use of these
tablets, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, these tablets can cause side effects,
although not everybody gets them.
Important side effects or signs to look out for, and
what to do if you are affected:
The most serious side effect is a condition where
you breathe more slowly or weakly than expected
(respiratory depression). It mostly occurs in elderly and
weak patients. Opioids can also cause a severe drop
in blood pressure in susceptible patients. If you are
affected by these important side effects, consult a doctor
immediately.
The following side effects have been seen in patients
being treated for pain
Common (may effect up to 1 in 10 people)
• abdominal pain
• constipation
• diarrhoea
• dry mouth
• indigestion
• vomit (be sick)
• feel sick
• flatulence (wind)
• decreased appetite up to loss of appetite
• a feeling of dizziness or ‘spinning’
• headache
• hot flushes
• a feeling of unusual weakness
• tiredness or exhaustion
• itchy skin
• skin reactions/rash
• sweating
• vertigo
• difficulty in sleeping
• drowsiness
Uncommon (may affect up to 1 in 100 people)
• abdominal bloating
• abnormal thoughts
• anxiety
• confusion
• depression

• muscle twitches
• muscle pain
• difficulties in passing urine
• increased urge to urinate
• generally feeling unwell
• weight loss
• weight increase
• a feeling of unusual weakness
• lack of energy
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. How to store Targinact tablets
Keep out of the sight and reach of children.
Do not use any tablets after the expiry date which is
stated on the carton and blister, after ‘EXP…’ The
expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package
in order to protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.
6. Contents of the pack and other information
What Targinact tablets contain
The active ingredients are oxycodone hydrochloride and
naloxone hydrochloride.
Targinact 5 mg/2.5 mg
Each 5 mg/2.5 mg prolonged-release tablet contains
5 mg of oxycodone hydrochloride, equivalent to 4.5 mg
oxycodone and 2.5 mg naloxone hydrochloride as
2.73 mg naloxone hydrochloride dihydrate, equivalent
to 2.25 mg naloxone.
Targinact 10 mg/5 mg
Each 10 mg/5 mg tablet contains 10 mg of oxycodone
hydrochloride, equivalent to 9 mg oxycodone and

What Targinact tablets look like and the contents of
the pack
Targinact 5 mg/2.5 mg tablets are blue, oblong tablets,
with a nominal length of 9.5 mm and with a film coating,
embossed “OXN” on one side and “5” on the other.
Targinact 10 mg/5 mg tablets are white, oblong tablets,
with a nominal length of 9.5 mm and with a film coating,
embossed “OXN” on one side and “10” on the other.
Targinact 20 mg/10 mg tablets are pink, oblong tablets,
with a nominal length of 9.5 mm and with a film coating,
embossed “OXN” on one side and “20” on the other.
Targinact 40 mg/20 mg tablets are yellow, oblong tablets,
with a nominal length of 14 mm and with a film coating,
embossed “OXN” on one side and “40” on the other.
In each box there are 28 or 56 tablets.
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge
CB4 0GW, UK.
Manufacturers:
Mundipharma GmbH
Mundipharma Straße 2, 65549 Limburg/Lahn, Germany
Bard Pharmaceuticals Limited
Cambridge Science, Milton Road, Cambridge
CB4 0GW, UK.

This leaflet is also available in large print, Braille or as an audio CD.
To request a copy, please call the RNIB Medicine Information line
(free of charge) on:

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Latest Drug Information Updates

TrogarzoTrogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug...

CimduoCimduo (lamivudine and tenofovir disoproxil fumarate) is a combination of two nucleo(t)side reverse...